Atorvastatin Calcium

Product NDC
68788-7900
Requested package NDC
68788-7900-1
11-digit product format
687887900
Labeler code
68788
Product ID
68788-7900_75445b2c-6a22-46d2-81fd-e89f2544aab8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209288
Marketing category
ANDA
Marketing start
2021-05-14
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-790068788-7900-1DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209288-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21
A209288-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21
A209288-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21
A209288-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A209288-001AB
A209288-002AB
A209288-003AB
A209288-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209288-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209288-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209288-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209288-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209288-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209288-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-004AB1d8e5a09893c0…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7900-1EA - Each68788-79003df7624f-87a0-4463-b728-549911c8556c12021-07-15
68788-7900-3EA - Each68788-79002effdb11-845d-4f6e-a1d7-0089f48ac85112021-07-15
68788-7900-6EA - Each68788-7900602a2cea-a9be-4d7d-a201-ae4006cb59a812021-07-15
68788-7900-9EA - Each68788-79003b66ead3-e487-4dc3-88d7-4c0a9fbd1ea012021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7900ATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]5Legacy NDC20250206_7fc504dd-718a-4340-825f-e19ed76b71ef.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUMREMEDYREPACK INC.09cb8375-075c-47e8-a4eb-8ac667ed849e2026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNorthwind Health Company, LLCc9f55cb6-a41b-dd27-e053-2a95a90aaeb72026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNorthwind Health Company, LLCf3084cae-db82-4e6f-e053-2995a90aa36a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNorthwind Health Company, LLCda6b77a5-2093-b7f7-e053-2995a90ab10d2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMQPharma, Inc.bd216f5d-f319-7d8d-e053-2a95a90aa9ce2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMQPharma, Inc.c0e2a5d0-1aa3-e131-e053-2a95a90a98702025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMREMEDYREPACK INC.57f9b462-f08e-483c-9b64-b7e4c8d469272025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMAsclemed USA, Inc.60d51f39-8086-4434-affe-88ab8ca0c7e52025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMAscend Laboratories, LLC67e60880-091a-4df7-8696-6e6c42a490e22025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepack2035c49b-f319-4dce-bf1c-c2f64e786fb72025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.95729689-8055-45ae-e053-2995a90a919f2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.8ee8b455-625c-ead6-e053-2a95a90aed292024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.862f9f27-c645-2d2e-e053-2991aa0a96b92024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.862f58d1-476c-2c90-e053-2991aa0ab8212024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions1cc2dd41-a465-45b6-a80a-67c41af29cf82024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions2ad89657-cc95-44a0-af6a-ee756526aa102024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions103cc381-3266-409d-bdc2-1de620bae3552024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutionse52b4b11-9618-4787-ae67-44e4a3166dfb2024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions0ec97c59-9d17-45f8-93f9-2c1f0361cb752024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutionse6d068ed-f9d2-4fd1-9755-b76bea89725e2024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7900-168788790001100 TABLET, FILM COATED in 1 BOTTLE (68788-7900-1) 2021-05-140000-00-00NoNoCurrent